ClearCalc

GUDID 00860001672725

ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

Radformation, Inc

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• Primary Device ID: 00860001672725
• NIH Device Record Key: af01931c-eee0-4223-aff0-06ecb1440921
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearCalc
• Version Model Number: 2.0
• Company DUNS: 080444608
• Company Name: Radformation, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001672725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193640

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-19
• Device Publish Date: 2021-10-11

Devices Manufactured by Radformation, Inc

• 00860001672725 - ClearCalc: 2021-10-19ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
• 00860001672725 - ClearCalc: 2021-10-19 ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations
• 00860001672732 - AutoContour: 2021-10-19 AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in p
• 00860001672701 - ClearCheck: 2021-10-12 ClearCheck is intended for quality assessment of radiotherapy treatment plans.
• 00860001672718 - EZFluence: 2021-10-12 EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homoge
• 00860001672749 - ChartCheck: 2021-10-12 ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imag